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Hemopro 2 Vasoshield (Maquet) – Ink Chip Hazard (2022)

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

High

FDADec 22, 2022Nationwide• Maquet Cardiovascular, LLC

Air-Q3 Airway Device (SunMed) – Tube Size Discrepancy (2022)

There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.

Low

FDADec 22, 2022Nationwide• SunMed Holdings, LLC

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Hemopro 2 Vasoshield (Maquet) – Ink Chip Hazard (2022)

Air-Q3 Airway Device (SunMed) – Tube Size Discrepancy (2022)

HydroMID Catheter Kit (Access Vascular) – Incorrect Label (2022)

Covera Vascular Stent (Bard) – Deployment Problem (2022)

Getinge Flow-c Anesthesia System (Getinge) – Ventilation Risk (2022)

HydroMID Catheter Kit (Access Vascular) – Mislabeling Issue (2022)

Medline Foot & Ankle Drill Bit (Medline) – Screw Failure Risk (2022)

Getinge Flow-i Anesthesia System (Getinge) – Ventilation Risk (2022)

myNeedle Guide Software (Siemens) – Orientation Label Error (2022)

RipCord Syndesmosis Button (TriMed) – Tension Failure Risk (2022)

ADVIA Centaur HBeAg Test (Siemens) – Interference Risk (2022)

EMPOWR VVC Knee Insert (Unknown) – Size Label Swap (2022)

Luminos Agile Max Imaging System (Siemens) – Collision Risk (2022)

Luminos Agile Imaging System (Siemens) – Collision Risk (2022)

Luminos dRF Max Imaging System (Siemens) – Collision Risk (2022)

Uroskop Omnia Max System (Siemens) – Collision Risk (2022)

Cobas Influenza Test (Roche) – False Negative Risk (2022)

EVIS EXERA III Colonovideoscope (Olympus) – Procedure Misuse (2022)

Cobas SARS-CoV-2 Test (Roche) – False Negative Risk (2022)

Luminos dRF Imaging System (Siemens) – Collision Risk (2022)